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Message-Id: <0402070550229.NP17997@jobcircle.com>
Newsgroups: alt.bestjobsusa.computer,alt.bestjobsusa.computer.jobs,alt.bestjobsusa.jobs.offered
From: recruiter@jobcircle.com (JobCircle.Com)
Reply-To: recruiter@jobcircle.com
Subject: US-NJ: SPARTA-Validation Technical Writer
Date: Sat, 07 Feb 2004 05:50:31 GMT
NNTP-Posting-Host: 207.106.112.162
NNTP-Posting-Date: Sat, 07 Feb 2004 00:50:31 EST
Organization: JobCircle.com (jobcircle.com)
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professionals in the Northeastern United States!
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and more to tens of thousands of Technology professionals in
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Job Title: Validation Technical Writer
Job Location: NJ: SPARTA
Pay Rate: DOE
Job Length: over 1 year (contract)
Start Date: 2004-02-06
Company Name: Phase II, Inc.
Contact: Recruiting
Phone: 908-756-9169 ext: 14
Fax: 908-766-1107
Description: Role:
Technical Writer
Organizational Structure:
-Reports to the project manager
Responsibilities:
- Author and edit the following validation documents:
o Experience Report (based on a system audit)
o Risk Assessment (based on a risk analysis)
o Validation Strategy Document
o User Requirements Specification
o Functional Requirements Specifications
o System Design Specification
o Traceability Matrix
o Installation and Operational Qualification
o Training Manual
o SOPs
o Laboratory Procedures
-Review:
o Error Manual
- Participate in project team meetings
- Participate in other project meetings as assigned
- Provide twice monthly time reporting of activities completed against project plans
- Participate in required training sessions
Background:
This position requires an undergraduate degree preferably in the life sciences and at least seven (7) years of experience in the pharmaceutical industry working with the scientific areas of the business authoring, reviewing and editing validation documents. The incumbent must have a working knowledge of Good Laboratory Practices (GLP), 21 CFR Part 11 and applicable laws and guidelines, system development lifecycle methodologies and best practices.
The incumbent must have excellent written and oral communication skills to participate in business requirements and review meetings. The incumbent must also have excellent listening skills to translate the spoken word into succinct documentation for assigned projects. Further, the incumbent must possess strong interpersonal skills to interact with multiple departments within the company and with external service providers. The incumbent must be flexible with shifting work plans and team dynamics to remain in keeping with the ever changing cultural environment while staying focused on compliance, quality and business objectives.
Applicant must be a U.S. resident or currently able to legally work in the U.S.
Please refer to Job code P2-1603 when responding to this ad.
For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/463438.html to apply online.
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For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
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